Nyxoah reports Q4 and financial year 2023 financial and operating results

Nyxoah SA reported financial and operating results for the fourth quarter and financial year 2023.

2024 strategic priorities

• Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April.
• File the fourth and final module in the modular PMA submission.
• Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch.
• Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study.
• Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe.

“In 2023, we completed enrollment in our DREAM U.S. pivotal study, presented positive early DREAM efficacy and safety data, initiated enrollment in our ACCCESS U.S. pivotal study for complete concentric collapse and raised capital from both existing and new investors. These accomplishments strengthen our confidence for a transformational 2024.” commented Olivier Taelman, Nyxoah Chief Executive Officer. “We are excited to report DREAM data in the coming weeks, finalize the regulatory FDA submission and pave the way for bringing Genio® to patients in the U.S.”

Taelman continued, “Commercially in Europe, this quarter’s performance was the strongest in Nyxoah’s history driven by a targeted direct-to-consumer (DTC) effort and I applaud our European commercial team for their execution. I look forward to a further increase in therapy penetration from our partnership with ResMed in Germany.”

Fourth quarter and full year 2023 results
Unaudited condensed consolidated financial information – consolidated statements of loss and other comprehensive loss for the three months and years ended December 31, 2023 and December 31, 2022 (in thousands)

Unaudited condensed consolidated financial information – consolidated statement of financial position as of December 31, 2023 and December 31, 2022 (in thousands)

Revenue
Revenue was €1.8 million for the fourth quarter ending December 31, 2023, compared to €1.3 million for the fourth quarter ending December 31, 2022. Revenue for the full year of 2023 was €4.3 million, compared to €3.1 million for the full year of 2022. The increase in revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

Cost of goods sold
Cost of goods sold was €726,000 for the three months ending December 31, 2023, representing a gross profit of €1.1 million, or gross margin of 60%. This compares to total cost of goods sold of €465,000 in the fourth quarter of 2022, for a gross profit of €842,000, or gross margin of 64.4%.

For the full year ending December 31, 2023, total cost of goods sold was €1.7 million, representing a gross profit of €2.7 million, or gross margin of 62%. This compares to total cost of goods sold of €1.2 million for the full year of 2022, for a gross profit of €1.9 million, or gross margin of 62.7%.

Research and development
For the full year ending December 31, 2023, research and development expenses were €26.7 million, versus €15.9 million for the full year of 2022.

Operating loss
Total operating loss for the fourth quarter and full year 2023 was €10.8 million and €45.1 million, respectively, versus €9.1 million and €32.5 million in the fourth quarter and full year 2022, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash position
As of December 31, 2023, cash and financial assets totaled €57.7 million, compared to €94.9 million on December 31, 2022. Total cash burn was approximately €4.6 million per month during 2023.
MB Bureau